Computer System Validation (CSV) Resource with SAP

Description

Qualifications BS Degree in Biology, Chemistry, Computer Science or related field.
At least 2 years of experience conducting validation of cGMP automation/computerized
systems within an FDA regulated environment. This would include drafting, facilitating
approval and conducting execution on typical validation deliverables (e.g., Validation Plans,
URS, FS, DS, IQ, OQ, PQ, UAT, Validation Summary Reports, SOPs).
Knowledge of cGMP regulations and guidelines including but not limited to U.S. Code of
Federal Regulations 21 CFR Part 11 and Part 211, EudraLex Volume 4 and Annex 11, and
ICH Q7, Q8, Q9 and Q10.
Thorough understanding of risk based validation lifecycle for computerized systems and best
practices such as GAMP 5
Key Responsibilities Ensure compliance with internal and external computerized system policies and regulations.
Conduct and facilitate computer system validation activities for automated lab equipment
software, data tracking and trending software, quality systems software and associated
business system interfaces.
Conduct Periodic Reviews per applicable policies and procedures to ensure that the
computer systems maintain their validated status.
Collaborate/lead/participate in decisionmaking and make recommendations regarding best
options for computer system validation.
Coordinate computerized system validation activities including organization of Subject
Matter Experts and System Owners for computerized system validation activities.
Deliver accurate updates with respect to scheduled computerized system validation
activities and report progress.
Ensure key personnel, training and experience is in place before beginning any
computerized system validation activities.
Support Regulatory inspections and internal and partner audits, and implement corrective
actions as needed. Provide CSV related responses to inspectors/auditors.